Roche has announced that its Elecsys® Dengue Ag test has received the CE mark, marking a significant advancement in the automation of dengue virus diagnostics. This fully automated immunoassay is designed to aid in diagnosing acute dengue virus infections and aims to enhance both the efficiency and reliability of dengue detection globally.
On October 29, 2025, Roche revealed that the Elecsys Dengue Ag test can swiftly deliver results in just 18 minutes. This rapid turnaround is crucial for healthcare systems, particularly during dengue outbreaks, where timely diagnosis can significantly impact patient management and treatment outcomes.
Dengue fever is recognized as the most prevalent mosquito-borne viral disease worldwide. The year 2024 witnessed an unprecedented surge in dengue cases, with over 14.6 million reported and more than 12,000 related fatalities across more than 100 countries. As the disease continues to spread, accurate and early diagnosis becomes increasingly vital for distinguishing dengue from other illnesses that cause fever, such as chikungunya and yellow fever.
Matt Sause, CEO of Roche Diagnostics, emphasized the importance of this new test in addressing the growing global health burden posed by dengue. “Dengue”s rapid worldwide spread has elevated it to a serious global burden, placing a significant strain on healthcare resources,” he stated. Roche”s commitment to supporting the response to infectious diseases is demonstrated through the introduction of this innovative diagnostic tool.
The Elecsys Dengue Ag test is specifically designed for use on Roche”s automated cobas® e immunoassay analyzers, including the cobas e 801 and cobas e 402 systems. These platforms are widely utilized in laboratories and can process between 120 to 300 tests per hour, thus improving lab efficiency and reducing manual errors.
Clinical studies have shown that the test can detect the NS1 antigen associated with all four dengue virus serotypes—DENV-1, DENV-2, DENV-3, and DENV-4—with a sensitivity of 94.90% in PCR-confirmed positive samples and a specificity of 99.96% in healthy blood donors. This high level of accuracy is crucial for effective patient management.
Additionally, Roche plans to expand its dengue testing capabilities with the introduction of the Elecsys Dengue IgM and IgG tests, which will complement the Elecsys Dengue Ag test. This comprehensive panel will address various stages of dengue diagnosis, including acute infection, recent exposure, and long-term immunity, thereby equipping healthcare providers with essential diagnostic tools.
Dengue is transmitted primarily through bites from infected female mosquitoes, particularly the Aedes aegypti species. While many individuals experience mild symptoms, a small percentage may develop severe dengue, which poses significant health risks, including bleeding and organ impairment. Global incidence rates are rising, exacerbated by climate change, which is expanding the mosquito”s habitat.
Overall, Roche”s Elecsys Dengue Ag test is a promising development in the fight against dengue fever, providing healthcare systems with a reliable means to diagnose the disease quickly and effectively, ultimately improving patient care during outbreaks.
For more information, visit www.roche.com.
